The thyroid cancer warning comes from rodents, not from people
In the adult trials, adjudicated acute pancreatitis occurred in four treated patients against one on placebo. The label says whether people get the rodent tumours is unknown.
What the study found
Gallstones ran 1.6% against 0.7%; the cancer warning is rodent-only
The serious events sit at a different volume from the common ones. In the adult trials, adjudicated acute pancreatitis occurred in four treated patients against one on placebo. The boxed warning covers thyroid tumours seen in rodents, and the label says whether people get them is unknown.
The caveat · Too few cases to size the risk
Four cases against one is too few to size the risk; it gives the order of magnitude and nothing more. The rodent finding is why anyone with a personal or family history of medullary thyroid cancer, a rare tumour of the thyroid, is told not to take it. The label lists further warnings the trials were never built to quantify, among them gallbladder disease, acute kidney injury and suicidal thoughts.